MAUDE Adverse Event Report: COOK INC INDY OTW VASCULAR RETRIEVER; MMX DEVICE, PERCUTANEOUS RETRIEVAL

Model Number	G51836
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k): k160593.The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
It was reported the customer found a piece of plastic-like foreign matter inside the unopened package.The package was not opened.No adverse effects to a patient were reported.
Additional Manufacturer Narrative
Additional information: concomitant medical products.Investigation: evaluation: a visual inspection of the returned device was conducted.A document based investigation was also performed including a review of the device history record, instructions for use, quality control data, and specifications.The indy-8.0-35-100-40 was returned still sealed within the packaging.There were no damages to the package observed.Two pieces of white foreign matter were identified sealed within the bottom left section of the package.A review of the device history record showed no non-conformances associated with the complaint device lot number: 9073860.A complaint history search revealed this to be the only reported complaint associated to the complaint lot number: 9073860.The device is shipped with our product ifu which contains warnings, precautions and instructions for use.The ifu states, ¿do not use the product if there is doubt as to whether the product is sterile.¿ the cause for this incident has been traced to manufacturing; a quality control deficiency.Per the quality engineering risk assessment, no further risk mitigating activity is required.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Event or Problem Description
There has been no new information received since the last report was submitted.

• Brand Name: INDY OTW VASCULAR RETRIEVER
• Common Device Name: MMX DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8016189
• Report Number: 1820334-2018-03078
• Device Sequence Number: 16583355
• Product Code: MMX
• UDI-Device Identifier: 00827002518360
• UDI-Public: (01)00827002518360(17)210807(10)9073860
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/07/2021
• Device Model Number: G51836
• Device Catalogue Number: INDY-8.0-35-100-40
• Device Lot Number: 9073860
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 10/29/2018
• Supplement Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1